FDA Breakthrough Status for Transcranial Electromagnetic Treatment (TEMT)

[Family Tree Guy]

For those who follow all the different innovative approaches being explored for treating AD (not just drug therapies), you may find this quite interesting:
https://www.bioworld.com/articles/49953 ... rs-therapy

They published a really interesting article last year describing incredible improvements in cognition for AD patients. Patients wear a skull cap that 'zaps' the brain 2 x per day for 1 hour. Unfortunately, their initial study did not include any E4 carriers, but hopefully the pivotal trial planned will. The idea is that the zapping clears out the A-beta plaques and Tau tangles.

If any of you closely follow the cancer treatment field, this reminds me very much of Novocure's Optune TTF (Tumor Treating Fields) which has been FDA approved for several years and has shown excellent impact on the very hardest of cancers (Glioblastoma).

[circular]

This is interesting, but I can’t help but wonder what other molecules in the subjects’ brains are breaking apart and possibly with adverse consequences, simultaneous endpoints that are’t being studied.

[Family Tree Guy]

@circular-- reasonable concern, though if somebody clearly has AD, then it becomes a risk-reward calculation. Probably would not make sense to do this TEMT therapy on healthy people, but I don't really see the downside for people who clearly have AD. My take is that this is an approach to keep an eye on. Very exciting early results, Very small study. It is a tiny company with no real money to conduct the ph3, so they will either need to raise money or establish a partnership with a larger org to do a full ph3 (which would likely need some type of placebo / sham device) Breakthrough status will give them good access to FDA for that study design if they can get the funding...

[circular]

@circular-- reasonable concern, though if somebody clearly has AD, then it becomes a risk-reward calculation.

I was thinking that too just after my post. Context is everything.